发明名称 |
Liquid, aqueous pharmaceutical compositions of factor VII polypeptides |
摘要 |
The present invention is directed to liquid, aqueous pharmaceutical compositions stabilised against chemical and/or physical degradation containing Factor VII polypeptides, and methods for preparing and using such compositions, as well as vials containing such compositions, and the use of such compositions in the treatment of a Factor VII-responsive syndrome. The main embodiment is represented by a liquid, aqueous pharmaceutical composition comprising at least 0.01 mg/mL of a Factor VII polypeptide (i); a buffering agent (ii) suitable for keeping pH in the range of from about 4.0 to about 9.0; and at least one stabilising agent (iii) comprising a —C(═N—Z1—R1)—NH—Z2—R2 motif, e.g. benzamidine compounds and guanidine compounds such as arginine.
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申请公布号 |
US8026214(B2) |
申请公布日期 |
2011.09.27 |
申请号 |
US20090617471 |
申请日期 |
2009.11.12 |
申请人 |
NOVO NORDISK HEALTH CARE AG |
发明人 |
JENSEN MICHAEL BECH;PETERSEN ANDERS KLARSKOV;BOWLER ANDREW NEIL |
分类号 |
A61K38/36;A61K31/17;A61K38/48;A61K47/16;A61K47/18 |
主分类号 |
A61K38/36 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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